Emerging technologies in genetics, pharmacogenetics, genomics, advanced therapies as well as ICT applications represent today the most advanced tools incorporated in the drug discovery and research & development process used for producing the largest part of the innovative medicines. Thus, regulation and guidance have to be continuously adapted and updated to guarantee clinical benefits, economic and health outcome improvements, as well as the respect of fundamental and patient rights.
Change in Regulatory Sciences is a continuous challenging process! The challenge is to align scientific and patients’ objectives with regulatory requirements along the whole development process of health products. Moreover, all the stakeholders should be aware of the criteria by which the authorisation and access to products will be measured and decided to cover patients’ specific needs.